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A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01942148
Recruitment Status : Completed
First Posted : September 13, 2013
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
The objective of this study is to investigate the safety and efficacy of aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over a period of 52 weeks in subjects who complete a short-term treatment study of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Long-term Safety Study of Aripiprazole (Initial Dose 2 mg/Day, Maintenance Dose 6-24 mg/Day, Maximum Dose 30 mg/Day) Orally Administered Over 52 Weeks in Patients Who Complete a Short-term Treatment Study of Aripiprazole in Pediatric Patients (Aged 13-17 Years) With Schizophrenia (031-09-003 Study)
Study Start Date : August 2010
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Aripiprazole
Aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over 52 weeks to subjects who complete the 031-09-003 study
Drug: Aripiprazole
Other Name: Abilify




Primary Outcome Measures :
  1. Mean Change From Baseline at Final Assessment in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Basline and Week52 ]
    The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7: 1 =Absent, 2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme. PANSS total score is calculated by adding score of 30 items, which ranges from 30-210. Higher scores indicate worse condition.


Secondary Outcome Measures :
  1. Mean Change From Baseline at Final Assessment in Clinical Global Impression-Severity of Illness (CGI-S) Score [ Time Frame: Basline and Week52 ]
    The Clinical Global Impression-Severity of Illness (CGI-S) Score is a clinician rated scale which assesses how mentally ill the patient is at the time. Scores range from 0 to 7: 0 = Not assessed, 1= Normal, not at all ill, 2 =Borderline mentally ill, 3= Mildly ill, 4= Moderately ill, 5= Markedly ill, 6= Severely ill, 7= Among the most extremely ill patients. Higher scores indicate worse condition.

  2. Mean Change From Baseline at Final Assessment in Children's Global Assessment Score (CGAS) [ Time Frame: Baseline and Week52 ]
    The Children's Global Assessment Score (CGAS) is a rating scale which measures psychological, social and school functioning for children aged 6-17. Scores range from 0 to 100, with higher scores indicating better condition.



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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to DSM-IV-TR
  • Male and female patients aged 13-17 years
  • Patients completing the 031-09-003 study
  • Patients who, in addition to their legal guardian, provide written informed consent, having understood the details of this study
  • Inpatient or outpatient status

Exclusion Criteria:

  • Patients who have a diagnosis of any other disease except schizophrenia, according to DSM-IV-TR
  • Patients who have been compulsorily admitted to hospital
  • Patients with mental retardation
  • Patients with thyroid disorder
  • Patients who fall under a contraindication listed in the ABILIFY package insert
  • Patients with a serious hepatic, renal, cardiac or hematopoietic disorder
  • Patients with a history or a complication of organic brain disorder or convulsive disorder such as epilepsy
  • Patients with a history or a complication of diabetes and patients who fall under any of the following: fasting blood glucose level ≧ 126 mg/dL, non-fasting blood glucose level ≧ 200 mg/dL, HbA1c ≧ 6.5%
  • Patients with a history or a complication of suicide attempt, suicidal thought or self-harm
  • Patients with a score of ≧2(mild) on PART1 evaluation of CGI-SS
  • Patients with a history or a complication of malignant syndrome, tardive dyskinesia or paralytic ileus
  • Patients in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition
  • Patients with a history or a complication of water intoxication
  • Patients with Parkinson's disease
  • Pregnant women, parturient women, nursing women, women of childbearing potential who wish to become pregnant during this trial. However, women of childbearing potential who are practicing an appropriate method of contraception (refer to 8.6) and have a negative pregnancy test result are eligible for inclusion in this study.
  • Study enrollment is otherwise judged to be inappropriate by the Investigator or Subinvestigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942148


Locations
Japan
Chubu Region, Japan
Chugoku Region, Japan
Hokkaido Region, Japan
Kansai Region, Japan
Kanto Region, Japan
Kyushu Region, Japan
Shikoku Region, Japan
Tohoku Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Kyoji Imaoka, Mr Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01942148     History of Changes
Other Study ID Numbers: 031-09-004
JapicCTI-101147 ( Other Identifier: JAPIC )
First Posted: September 13, 2013    Key Record Dates
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017
Last Verified: April 2017

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Schizophrenia, Pediatric patients

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs